Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease
Por:
Kroger, N, Solano, C, Wolschke, C, Bandini, G, Patriarca, F, Pini, M, Nagler, A, Selleri, C, Risitano, A, Messina, G, Bethge, W, de Oteiza, JP, Duarte, R, Carella, AM, Cimminiello, M, Guidi, S, Finke, J, Mordini, N, Ferra, C, Sierra, J, Russo, D, Petrini, M, Milone, G, Benedetti, F, Heinzelmann, M, Pastore, D, Jurado, M, Terruzzi, E, Narni, F, Volp, A, Ayuk, F, Ruutu, T, Bonifazi, F
Publicada:
7 ene 2016
Resumen:
BACKGROUND
Chronic graft-versus-host disease (GVHD) is the leading cause of later illness and death after allogeneic hematopoietic stem-cell transplantation. We hypothesized that the inclusion of antihuman T-lymphocyte immune globulin (ATG) in a myeloablative conditioning regimen for patients with acute leukemia would result in a significant reduction in chronic GVHD 2 years after allogeneic peripheral-blood stem-cell transplantation from an HLA-identical sibling.
METHODS
We conducted a prospective, multicenter, open-label, randomized phase 3 study of ATG as part of a conditioning regimen. A total of 168 patients were enrolled at 27 centers. Patients were randomly assigned in a 1:1 ratio to receive ATG or not receive ATG, with stratification according to center and risk of disease.
RESULTS
After a median follow-up of 24 months, the cumulative incidence of chronic GVHD was 32.2% (95% confidence interval [CI], 22.1 to 46.7) in the ATG group and 68.7% (95% CI, 58.4 to 80.7) in the non-ATG group (P<0.001). The rate of 2-year relapse-free survival was similar in the ATG group and the non-ATG group (59.4% [95% CI, 47.8 to 69.2] and 64.6% [95% CI, 50.9 to 75.3], respectively; P=0.21), as was the rate of overall survival (74.1% [95% CI, 62.7 to 82.5] and 77.9% [95% CI, 66.1 to 86.1], respectively; P=0.46). There were no significant between-group differences in the rates of relapse, infectious complications, acute GVHD, or adverse events. The rate of a composite end point of chronic GVHD-free and relapse-free survival at 2 years was significantly higher in the ATG group than in the non-ATG group (36.6% vs. 16.8%, P=0.005).
CONCLUSIONS
The inclusion of ATG resulted in a significantly lower rate of chronic GVHD after allogeneic transplantation than the rate without ATG. The survival rate was similar in the two groups, but the rate of a composite end point of chronic GVHD-free survival and relapse-free survival was higher with ATG. (Funded by the Neovii Biotech and the European Society for Blood and Marrow Transplantation; ClinicalTrials.gov number, NCT00678275.)
Filiaciones:
Kroger, N:
Univ Med Ctr Hamburg Eppendorf, Hamburg, Germany
Solano, C:
Hosp Clin Univ, Valencia, Spain
Wolschke, C:
Univ Med Ctr Hamburg Eppendorf, Hamburg, Germany
Bandini, G:
Univ Bologna, S Orsola Malpighi Univ Hosp, Bologna, Italy
Patriarca, F:
Univ Udine, DISM, Hematol, Udine, Italy
Pini, M:
Azienda Ospedaliera SS Antonio & Biagio & C Arrig, Alessandria, Italy
Nagler, A:
Chaim Sheba Med Ctr, Ramat Gan, Israel
Selleri, C:
Univ Naples Federico II, Naples, Italy
Univ Salerno, I-84100 Salerno, Italy
Risitano, A:
Univ Naples Federico II, Naples, Italy
Messina, G:
AO Bianchi Melacrino Morelli, Reggio Di Calabria, Italy
Bethge, W:
Univ Hosp Tubingen, Tubingen, Germany
de Oteiza, JP:
Hosp Ramon & Cajal, E-28034 Madrid, Spain
Duarte, R:
Hosp Univ Puerta Hierro Majadahonda, Madrid, Spain
Carella, AM:
Osped Casa Sollievo Sofferenza IRCCCS, San Giovanni Rotondo, Italy
Cimminiello, M:
Azienda Osped San Carlo, Potenza, Italy
Guidi, S:
Azienda Osped Careggi, Florence, Italy
Finke, J:
Univ Hosp Freiburg, Freiburg, Germany
Mordini, N:
Osped Santa Croce & Carle, Cuneo, Italy
Ferra, C:
Hosp Badalona Germans Trias & Pujol, Inst Catal Oncol, Serv Hematol, Badalona, Spain
Sierra, J:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Russo, D:
Univ Brescia, Dept Clin & Expt Sci, Brescia, Italy
Petrini, M:
Univ Pisa, Dept Clin & Expt Med, Pisa, Italy
Milone, G:
Azienda Policlin Vittorio Emanuele, Programma Trapianto Emopoiet Metropolitano, Catania, Italy
Benedetti, F:
Policlin GB Rossi, Verona, Italy
Heinzelmann, M:
Univ Med Ctr Hamburg Eppendorf, Hamburg, Germany
Pastore, D:
Univ Osped, Azienda Osped, Bari, Italy
Jurado, M:
Hosp Virgen Nieves, Granada, Spain
Terruzzi, E:
Osped San Gerardo, Monza, Italy
Narni, F:
Policlin Modena, Modena, Italy
Volp, A:
Psy Consult, Frankfurt, Germany
Ayuk, F:
Univ Med Ctr Hamburg Eppendorf, Hamburg, Germany
Ruutu, T:
Helsinki Univ Hosp, Helsinki, Finland
Bonifazi, F:
Univ Bologna, S Orsola Malpighi Univ Hosp, Bologna, Italy
Green Published, Bronze
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